510(k) K243185 ยท OMC Reduced- Montage Standard Electroencephalograph
REMI Remote EEG Monitoring System
| Applicant | Epitel, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Mar 21, 2025 |
| Received | Sep 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243185
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.